Open Access News

News from the open access movement

Sunday, May 20, 2007

More on OA to clinical drug trial data

Pat McCaffrey, Clinical Trial Data: Fit for Public ConsumptionAlzheimer Research Forum, March 13, 2007.  Excerpt:

This week, two independent groups of academic researchers call for more transparency in the conduct of clinical trials. One focuses on the structure of industry-academic partnerships in clinical trials, while the other argues for a more open airing of safety results from large-scale clinical trials that are submitted to the United States Food and Drug Administration (FDA)....

[According to Piccart et al. in Nature] academic independence and openness with the data is the key to successful clinical investigation. “Only by ensuring untrammeled access to long-term data, both good and bad, can we conduct clinical trials in a credible manner,” the authors conclude. “This access will ensure that those patients who consent to participate in them maintain faith in the clinical trial process.”

That theme of the importance of open access to data is echoed in the second report, from Aaron Kesselheim from the Brigham and Women’s Hospital and Michelle Mello of the Harvard School of Public the March/April issue of Health Affairs.

When companies conduct a trial, all the safety and efficacy data is submitted to the FDA. The primary data stays under wraps, with the results presented in a summary report, which is often written by the applicant company. The presumption behind this scheme is that releasing the raw data could harm the business interests of the company by helping their competitors....

Kesselheim and Mello question whether the FDA’s default policy of keeping safety data secret is consistent with public’s interest in disseminating the information, which not only protects people using existing drugs, but also can help efforts to make future drugs safer.

While it may be true that the release of some kinds of information, such as data on chemical composition and formulation, and sometimes efficacy, can put companies at a disadvantage, this is rarely the case with safety data, the authors write....


Piccart M, Goldhirsch A, Wood W, Pritchard K, Baselga J, Reaby L, Kossler I, Kyriakides S, Norton L, Coates A. Keeping faith with trial volunteers. Nature. 2007 Mar 8;446(7132):137-8. Abstract

Kesselheim AS, Mello MM. Confidentiality laws and secrecy in medical research: Improving Public Access to Data on Drug Safety. Health Affairs. 2007 March; 26(2): 483-491. Abstract